1. Field of the Invention
The invention relates to the connection of an accessory to a receptacle.
More especially, its purpose is a device for connection to a receptacle of an accessory whose active proximal part is able to be put into communication with the inside of the receptacle by means of an opening of the receptacle; whereby a first unit comprises a connecting device and an accessory; whereby a second unit comprises the first unit and a receptacle comprises an opening in which the connecting device is mounted; a process for mounting the second unit; and a process for implementing the second unit.
In this case, the receptacle in question is a receptacle for storage and/or for treatment of contents such as a biopharmaceutical product. In this case, such a receptacle is understood to be a reusable rigid receptacle or a disposable flexible receptacle such as a pocket.
2. Description of the Related Art
This pocket can be a so-called 2D pocket, such as the one marketed by Sartorius Stedim Biotech under the trademark Flexboy®, whose volume can typically be between 50 milliliters and 50 liters.
The document WO 00/04131 describes such a flexible receptacle whose volume can exceed—and generally does exceed—50 liters. Such a receptacle is commonly called a 3D pocket. It is then known that rigid means for holding the pocket from the outside, at least when it comprises its contents, are associated with this pocket.
In this case, a biopharmaceutical product is understood to be one (or several) product(s) that are obtained from biotechnology—culture media, cellular cultures, buffer solutions, artificial nutrition liquids, blood products and derivatives of blood products—or a pharmaceutical product or more generally a product that is designed to be used in the medical field. Such a product is in liquid, pasty, or powdery form in one or more phases that may or may not be homogeneous. The invention also applies to products other than biopharmaceutical products, according to the definition that was just given, but is subject to analogous requirements regarding their storage or their treatment.
In this case, the accessory is understood to be a probe for measuring parameters that are relative to the contents of the receptacle, such as pressure, pH, temperature, colorimetry, conductimetry, etc., or else a filling tube or a drainage tube. The invention also applies to other accessories but those whose purpose is to be connected to a receptacle by being put into communication with the inside of the latter.
In the field of biopharmacy, it is common to use receptacles as the site for carrying out chemical or biological reactions, and, if necessary, to follow and/or monitor them, or else as a storage means. So as to prevent germs from penetrating inside the receptacle, it is important that the environment be closed, sterile and aseptic, without contact with the outside environment.
The reactions in general should take place under determined and monitored conditions (pressure, pH, temperature, colorimetry, conductimetry, etc.) or the storage should be implemented under controlled conditions. It is therefore necessary to carry out measurements or monitoring of parameters that characterize the product that is contained in the receptacle more or less frequently. These measurements should be carried out under aseptic conditions, for the reasons indicated above.
The document DE 10 2004 015703 describes a device for connecting an accessory to a receptacle that comprises two elements that are provided with guide means and hooks. This device comprises neither a third element to which the accessory is intended to be attached and that comprises a protective top and a base, nor a chamber.
The document DE 42 07 845 describes a support device for an analytical electrode, comprising a stationary outer tube, a moving, sliding inner tube, and a unit that is mounted transversely and that includes a piston that is mounted in a casing, whereby this unit can form an airtight inlet for the inner tube so as to be able to withdraw the electrode from the receptacle in which it is intended to be placed, without losing the contents of the latter. The purpose of this device is not the composition of a functional chamber.
The document WO 86/07 151 describes a maintenance device for the calibration and the automatic cleaning of a probe that is part of a continuous measuring system of the chemical or biological process, consisting in analyzing parameters of the fluid that is to be investigated.
The document DE 25 57 542 describes a measuring device for electrical values of media that flow, with measuring detectors that are placed in passage chambers, in which the passageway of a valve body forms the passage chamber and the detector is mounted in the latter.
The document US2005/0239199 describes a probe according to a particular arrangement.
The document US2005/0239198 describes a sterile and aseptic connection by means of two elements, a first element that is attached to the receptacle and a second element that can be connected to the first element. The first element comprises, at its free end, a connecting means that is provided with a cover. The second element comprises a probe that is placed inside a flexible sleeve that is provided with a connecting means that is provided with a cover, whereby the connecting means of the second element is designed to be connected to the connecting means of the first element after their respective covers are removed. The probe is attached to the receptacle by sliding the connecting means of the second element into the connecting means of the first element. The end of the probe is then inserted inside the receptacle by compression of the sleeve, whereby the probe slides inside the first element until it reaches the inside of the receptacle.
There is therefore a need for ensuring an airtight connection of an accessory to a receptacle, an easy and quick insertion of the accessory into the receptacle, and, if necessary, a calibration of the accessory when the latter is a probe, and a permanent protection of the accessory. This requirement should be satisfied with a simple device and by means of a process for easy and risk-free implementation.